The primary purpose of this study is to determine the maximum tolerated dose (MTD) of MT-201-GBM (pp65CMV antigen monocytes) that will be administered to patients newly diagnosed with a type of brain tumor called glioblastoma (GBM) that has an unmethylated MGMT (O\[6\]-methylguanine-DNA methyltransferase) (MGMT) gene promoter.
The investigational vaccine (MT-201-GBM) in this study is made from a type of immune cell called monocytes, which have been engineered to express a cytomegalovirus (CMV) protein. The monocyte vaccines are made from the patient's own cells, which are collected through a procedure called leukapheresis. During leukapheresis, the patient's blood is collected into a machine that removes white blood cells and then returns the remainder of the blood back to the individual. The leukapheresis procedure is not typically associated with any discomfort or pain. The white blood cells collected from leukapheresis are used to generate the patient's monocyte vaccine. After leukapheresis, patients receive standard radiation therapy combined with temozolomide for about 6 weeks, followed by one cycle of temozolomide for 21 days. About 2 days later, patients will receive the first monocyte vaccine, followed by 2 more monocyte vaccines every 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
monocytes isolated from patient's leukapheresis loaded with CMV pp65-LAMP (Lysosomal-associated Membrane Protein) mRNA (Messenger Ribonucleic Acid)
Maximum Tolerated Dose (MTD) of MT-201-GBM
Dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate of 0.25.
Time frame: 1 month after first infusion
pp65 T-cell Immune Response After 2 Weeks Post Infusion Three Compared to Baseline
Mean (or median) change from baseline within each dose level for IFN gamma, granzyme-B, and fluorospot
Time frame: 2 weeks after third infusion
Percentage of patients with a dose-limiting toxicity (DLT) during DLT observation period within each dose level
To assess safety and tolerability of MT-201-GMB, the percentage of patients with a dose-limiting toxicity (DLT) during the DLT observation period within each dose level will be estimated.
Time frame: 1 month after first infusion
Median Overall Survival (OS)
Survival from start of MT-201-GBM
Time frame: 2 years
Median Progression Free Survival (PFS)
Time to first recurrence after start of MT-201-GBM
Time frame: 2 years
pp65 T-cell Immune Response After Each Infusion Compared to Baseline
Mean (or median) change from baseline to peak levels within each dose level for IFN gamma and ELISpot
Time frame: 2 weeks after third infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.